There are three types of compositions available that can be hygienically administered to the vaginal zone. The simplest is essentially water acting as a cleansing agent. A second type contains povidone-iodine. This product is effective against bacteria, but not against fungi. The presence of normal bacterial flora in the vagina is desirable, should not be reduced, and does not cause discomfort. The presence of fungal overgrowth in the vagina is undesirable causing discomfort and infection. Therefore, povidone-iodine is considered to be unsuitable for preferred hygienic administration to the vaginal area.
A third type of treatment consists of pharmaceutically acceptable fungicidal/fungistatic compositions which are effective. However, the methods of application for these products are cumbersome and insufficiently effective. The products that are supplied in tablet form require insertion into the vagina with the aid of a mechanical device. The tablet thereafter disintegrates and is distributed throughout the vagina to come in contact with the fungi in order to be effective. This method of treatment is not very effective. Miconazole nitrate supplied in a cream formulation is also cumbersome to apply vaginally and the difficulty of thorough distribution to all tissue surfaces reduces its effectiveness.
In reviewing prior art patents, relative to the preparation of this application there were uncovered U.S. Pat. Nos. 3,011,946 (Bartner et al) ; 4, 195, 172 (Falkowski et al) and 4,102,998 (Gutnick).
The Bartner patent develops an aqueous solution of nystatin which is highly soluble in an aqueous solution of a soluble saccharin. The discovery discloses that the incorporation of benzyl alcohol into the solution imparts an improved solubility to the nystatin. According to the patentee, nystatin preparations are parenterally administered and administration is intended to be by injection in an intramuscular or intravenous fashion. This is different from the administration of a vaginal douche by means of a nozzle or the like.
The Falkowski patent relates to salts of various compounds including nystatin which are of very high water solubility. The resulting compounds are said to exhibit antifungal activity. This patent relates to injectable solutions and not to the administration of douches. One of the specified nystatin salts derived is N-methylglucamine salt of the N-glycosyl derivative of nystatin.
The Gutnick patent relates to a process for the prevention of venereal disease. It embodies a metal intrauterine contraceptive device for medication, which is released gradually into the vagina and the lower end of the uterus over a prolonged period of time. This patent relates to antibacterials and antibiotics and the device includes a magnet. Reference is also made to antifungal activity in other places in the text of this patent, but nystatin is referred to as an antibiotic with antifungal activity. No reference is made to a water soluble nystatin.
None of the known prior art nor the forgoing patents relates to the preparation of a fluid douche especially suited for killing or inhibiting fungi such as yeast in the vaginal zone while being at most marginally effective with respect to bacteria.